Consumer Advertisements for Psychostimulants in the United States: A Long History of Misleading Promotion

The prescription of psychotropic medications for children continues to be a controversial area of medical practice. In the United States, academic medical centers, medical researchers, prescribers, and the FDA are all ostensibly committed to the common goal of disseminating accurate information and promoting treatment based on scientific evidence. In the United States, however, medical treatment takes place in the context of legal and pervasive direct-to-consumer advertising (DTCA). There are concerns about the potential for DTCA to affect public health negatively and to increase health care costs.1,2

In 2005, we wrote to the FDA regarding a perceived disconnect between widespread DTCA for attention-deficit/hyperactivity disorder (ADHD) medications and the peer-reviewed scientific literature.3 Such a disconnect is important because FDA regulations require that DTCA be consistent with the FDA-approved product label.4 The FDA notified us that it would further evaluate our concerns,5 but the advertisements continued. Three years later (on September 26, 2008), the FDA issued letters to 5 pharmaceutical companies that sell psychostimulants (eg, methylphenidate and mixed amphetamine salts), warning them to cease misleading promotion—including advertisements to both prescribers and consumers.6 The warning letters state that among other alleged infractions, the targeted advertisements overstate the efficacy of psychostimulants.

Some might question the delay in regulatory response. However, our central question is, where has the mainstream medical community been over the past 3 years while—as the FDA has now acknowledged—Americans were being misled about psychiatric drugs for children?

As anyone familiar with the treatment of children with an ADHD diagnosis already knows, psychostimulant medications represent but 1 type of intervention used with this population and are by no means a “magic bullet” treatment. Both the evidence-based literature and even the prescribing labels for psychostimulants acknowledge the need for a comprehensive treatment program in the treatment of ADHD.7,8 There is also a paucity of research demonstrating that the prescription of stimulants predictably results in enhanced socioemotional development.

Therefore, when we wrote to the FDA in 2005, we were concerned about a highly visible US advertising campaign for Adderall that featured smiling children and their parents. The advertisements were widely distributed in popular periodicals, such as People magazine, and they claimed that Adderall was a “trusted solution for ADHD” that would lead to “friends that ask him to join the group” and a “family hour that lasts for hours.” The Web site featured a celebrity endorsement by television personality Ty Pennington, in which he claimed that Adderall did not affect his appetite or sleep.9 All of these advertising claims exaggerated the positive impact of this medication as measured by scientific evidence.10

For instance, academic difficulties are often a precipitating factor in the diagnosis and treatment of ADHD, and thus parents may find claims that psychostimulants increase academic performance particularly compelling. For years, Adderall advertisements have used the slogan, “Schoolwork that matches his intelligence.”9 In 2005, we wrote to Shire Pharmaceuticals regarding this claim, pointing out that the experimental evidence was limited to improvement on a 10-minute math test, and questioning whether this was equivalent to the more global concept of “schoolwork.”11 At the time, Shire defended its advertising campaign.12 The FDA has subsequently clamped down on the gap between peer-reviewed scientific evidence and such claims, noting that an improvement on ADHD measures does not necessarily correlate with improved academic outcomes, and warning Shire directly that “improvement in attention, as evidenced by increased numbers of math problems answered correctly, has not been correlated with an improvement in academic performance throughout the day, an end point which has not been studied.”13